510(k) Report

FDA applicant

Microlife Corp.

Great Neck, NY16 decisions2000–20260 recalls

FDA records 16 decisions for Microlife Corp. (Great Neck, NY) from 2000 to 2026: 16 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Its devices cite 17 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Microlife Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Microlife Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22008: 12013: 12025: 12026 (partial year): 2
2007high 2 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Microlife Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Microlife Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive10decisions
  • FLLContinuous Measurement Thermometer3decisions
  • BZHMeter, Peak Flow, Spirometry2decisions
  • LHDDevice, Fertility Diagnostic, Proceptive1decision

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 29 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 20046cite it
  • K020725Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 20024cite it
  • K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp. · 20083cite it
  • K013485Microlife Upper Arm Automatic Blood Pressure Monitor, Model BP-3BTO-1, with Optional Thermal Printer, Model…Microlife Corp. · 20023cite it
  • K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 20073cite it
  • K003308Microlife Digital Infrared Ear Thermometer, IR1DAI, IR1DB1, IR1DD1Microlife Corp. · 20002cite it

What has FDA decided for it lately?

  • K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife Corporation · 2026
  • K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation · 2026
  • K251120Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)Microlife Corporation · 2025
  • K122013Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Cardio+ (BP4GAPO-2M)Microlife Corp. · 2013
  • K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp. · 2008
  • K073398Microlife Wrist Watch Blood Pressure Monitor, Model BP3MK1-3 (BP W100)Microlife Corp. · 2007
  • K073397Microlife Upper Arm Manual Blood Pressure Monitor, Model BP3MR1-H (BP A50)Microlife Corp. · 2007
  • K041411Microlife Upper Arm Blood Pressure Monitor, Model BP-3BTO-APMicrolife Corp. · 2004

All 13 as Microlife Corp. →All 3 as Microlife Corporation →

Other applicant names beginning “Microlife”

FDA records each applicant name separately; these may or may not be the same firm.

Microlife Intellectual Property GmbH 54Microlife Intellectual Property GmbH, Switzerland 3Microlife Intellectual Property Gmb 1Microlife Systems AG 1